LETTERS TO THE EDITOR

Similar is the problem with oral Rakesh Lodha, combinations such as amoxicillin-clavulanic S.K. Kabra, acid available in India. To overcome this Department of Pediatrics, problem, we suggest following solutions: All India Institute of Medical Sciences, (i) It will be preferable to mention only the New Delhi 110 029, India. amount of active drug in the injection vial/ E-mail: [email protected] oral preparation prominently and the contents REFERENCES could give the details. For example, vial of a combination of cefoperazone (500 mg)- 1. Toltzis P, Blumer JL. Antibiotic resistance. In: Feigin RD, Cherry JD, Demmler GJ, Kaplan sulbactam (500 mg), currently labeled as 1 g, SL. Textbook of Pediatric Infectious Diseases. could be labeled as 500 mg; (ii) The 5th Edn, Saunders, Philadelphia. 2004: physicians and nurses should take care while pp 2944-2965. prescribing / administering and should clearly 2. Mathai D, Rhomberg PR, Biedenbach DJ, Jones mention / administer the dose of the active RN. India Antimicrobial Resistance Study compound. Group. Evaluation of the in vitro activity of six broad-spectrum beta-lactam antimicrobial We will like to alert the pediatricians about agents tested against recent clinical isolates this error so that they can identify this and take from India: a survey of ten medical center corrective actions. laboratories. Diagn Microbiol Infect Dis. 2002; 44: 367-377.

How Baby Friendly are the Baby acetate 0.1%, vitamin A and D3 mixture 0.1%, Products? 0.015%(1). Liquid paraffin is a documented emollient to be applied for rashes, itching and dry . It is not massage, . But the label on this oil reads “It is ideal massage Recently there has been controversy about oil for your baby. Daily massage has clini- baby products of a famous Multinational cally shown to benefit baby’s growth and company. A child in Amaravati, Maharashtra, development”. For baby massage vegetable developed blisters after application of its baby have been shown to be superior to products oil. Oil application was stopped and the blisters containing (2). Vegetable oils subsided. Subsequently a complaint was significantly improve growth as well as blood lodged with the FDA (Food and Drug flow as compared to the mineral oil. Vegetable Administration), Maharashtra. It was dis- oils are well absorbed from the skin. Further, covered that a total of thirty-nine complaints mineral oils may clog the pores of the skin and were filed with this company from January can cause allergic reactions. The label on baby 2004 to February 2005 for skin reactions oil also claims it is vitamin D enriched whereas following use of baby oil, but the company did its vitamin D content is only 0.1% together not initiate any action. with vitamin A and the claim of beneficial In this company’s baby oil, liquid paraffin effect accruing from such low concentrations amounts to 99.78%, rest being tocopheryl could not be substantiated by the company.

INDIAN PEDIATRICS 367 VOLUME 43__APRIL 17, 2006 LETTERS TO THE EDITOR

As regards baby shampoo of this company regulation of manufacture, sale and distribu- FDA Maharashtra has said that “this product is tion of Drugs is the concern of the State a misnomer to be a baby product; company’s authorities while the Central Authority (Drug claims regarding benefits accruing from its use Controller of India) is responsible for approval are substantiated by data obtained from clinical of new drugs, clinical trials in the country and trials conducted on adult citizens in USA”. laying down the standards for Drugs, etc. So FDA Maharashtra has also cited various the state and central bodies have to work in discrepancies in claims made by the company tandem to address such issues. Consumer with regards to this company’s baby milk soap, activists should also take up the issue of baby , baby milk lotion, baby hair oil etc. awakening the community from the ill effects / hazards due to unnecessary use of such In its order FDA had asked this company to products. TV / print advertisements should be drop the word “baby” from its products meant modified or banned as they are the modes of for infants. FDA had also served a notice on the aggressive sale promotion and parental company asking it to provide substantial misguidance. clinical evidence to prove that its Baby Oil brand is safe for use by children, as claimed in IAP is expected to perform its role as a the product’s label. In China also, Taipei City watchdog to protect the health and ensure the Government’s health authorities have been rights of a child consumer. IAP should alert instructed to conduct examinations of the itself to this important matter and issue company’s baby products. But this is not the guidelines on this matter to pediatricians as only company selling such products. In chaotic well as related Government bodies. and unregulated Indian market there is a Mukul Tiwari, plethora of baby products with questionable Apex Hospital,University Road, claims and ingredients, some of them by Gwalior (M.P.), India. reputed companies. FDA has also initiated E-mail: [email protected] action against such companies(3). C.P. Bansal, This issue needs a thorough discussion and Consultant Pediatrician, raises some questions. Scientifically, is there a Shabd Pratap Hospital, need for specialized oil, lotion, shampoo, Vinay Nagar, Gwalior (M.P.), India. powder and soaps for the use of newborns and E-mail: [email protected] infants? If yes then what are the criteria and REFERENCES guidelines for their composition and suitability 1. Order passed by Food and Drug Adminis- to babies? If no, then why these products are in tration, Maharashtra State, S.No. 341. Baby the market? Items sold as baby products are Cosmetics Products. http//www.maharashtra. expensive as compared to the traditional gov.in/pdf/press_note. Date of access 1.6.05 products. Aggressive promotion in the print 2. KN Agarwal, Ashish Gupta, Ravi Pushkarna, and electronic media have resulted in mothers SK Bhargava, MMA Faridi, MK Prabhu. and young parents buying these products at Effects of massage and use of oil on growth, fancy prices believing that these products blood flow & sleep pattern in infants. Indian J have special attributes that help growth, Med Res 112, December 2000, pp 212-217. development and health of the babies. 3. News item–FDA targets more companies. www.domain-b.com/marketing/ general/2005/ Under the Drug and Cosmetics Act, the 20050415_targets Date of access 1.7.05.

INDIAN PEDIATRICS 368 VOLUME 43__APRIL 17, 2006